Smart phone vision testing system

ABSTRACT

A handheld smart phone includes programming for performing various vision-related tests. The smart phone includes a touch sensitive screen, microphone, speaker, other sensors, processor and persistent storage for execution of software, multiple communications network interfaces and other device interfaces. The display delivers vision tests and, together with the speaker, related audio instructions to a user. The user interacts with the vision tests by using tactile and audio commands to the device screen and microphone. The test results are assembled into a report that can be transmitted to persons of the user&#39;s choice, such as a care provider. The capability is included for transmitting results to the remainder of the system for storage, analysis, events, alerts for medical personnel&#39;s user treatment and multiple user population analysis.

CROSS REFERENCE

This application claims priority from U.S. Application No. 62/607,317entitled Multi-Part Eye Test Grid Report for Mobile Device, filed Dec.19, 2017, and incorporated by reference herein in its entirety.

TECHNICAL FIELD

This disclosure relates to techniques for the design and implementationof a system for assembling reports from the execution of vision andrelated tests on a mobile wireless device, including data storage,analysis and reporting. In particular, the recognition and control ofmedical eye defects can be facilitated by using a report constructedfrom the assembly of multiple images resulting from vision testing on amobile wireless device, such as a smart phone, for use with individualusers, medical practitioners and researchers of multiple-userpopulations.

BACKGROUND

Vision testing is performed today primarily through professionalevaluation using a variety of simple and advanced medical diagnostictools in professional hospital and clinic settings. Professionalevaluation is effective in analyzing many vision disorders, howeverlacks an important capability to detect changes quickly and in theuser's daily environment with the resulting failure of timelyadministration of medication and the performance of medical procedures.There are some vision diseases, such as diabetic retinopathy,age-related macular degeneration, and other vision diseases and sideeffects from pharmaceuticals where ongoing monitoring of vision iscritically important. Such diseases and pharmaceuticals may becomeactive at unpredictable times in ways that affect the eye. If theseeffects are not promptly detected and treated, they could result in anirrecoverable vision loss in a matter of weeks or even blindness. Thenormal practice of relying on routine visits every 4 to 6 months leavesthe patient vulnerable to these undiscovered changes.

Adaptation of the user's personal smart phone with a system for visiontesting can give users at all locations and all times the ability toconveniently monitor their vision, identify changes, and report resultsfor rapid evaluation. The system includes techniques for assessment ofthe user's testing accuracy. Additionally, the system solves a criticalproblem found in other handheld user operated devices, namely, theproblem of care provider data overload from receiving high volumes ofuser generated test results, namely, where a small number of results areimmediately significant for the user's care, but where all results mustbe reviewed due to liability consequences. The ability of the system todo rules-based filtering of incoming tests based on care providerpreferences and provide only the significant test results to theprovider for prompt review is a major benefit to the care providersability to use the system effectively.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic diagram illustrating a user/patient using a smartphone to perform vision tests on the user's own eyes and generate areport for personal use.

FIG. 1B is a schematic diagram illustrating one embodiment of a systemin which the user communicates vision test results to the system forstorage, analysis, trends, reports, events, actions, services and whichis accessible to the user's care providers.

FIG. 2A1 is a simplified example of a vision-related report created bythe Mobile App (MA) portion of this system showing one example of thecurrent test results for one or both eyes formatted in one column fordisplay on the user's smart phone screen

FIG. 2A2 is a simplified example of a vision-related report created bythe MA providing one example of current test results for one or botheyes formatted in two columns for user's smart phone printing ortransmission to someone, for example user's eye care provider.

FIG. 2B1 illustrates one example of a report created by the serverportion of this system including the user's current test results madedirectly available for review by the user's eye care provider.Illustrated here is the left column of the report.

FIG. 2B2 illustrates one example of a server report including the user'scurrent test results made directly available for review by the user'seye care provider. Illustrated here is the right column of the report.

FIG. 2C1 illustrates one example of a server trend report including theuser's one-month historical and comparative results and trends fromprevious and current tests made directly available for review by theuser's eye care provider. An alternative for trend presentation providesa 30 day or longer sliding window. Illustrated here is the left columnof the report.

FIG. 2C2 illustrates one example of a server trend report including theuser's one month historical and comparative results and trends fordirect review by the user's eye care provider. Illustrated here is theright column of the report.

FIG. 2D1 illustrates one example of a server trend report like FIG. 2C1however providing context over a six-month timeframe. Illustrated hereis the left column of the report.

FIG. 2D2 illustrates one example of a server trend report like FIG. 2C2however providing context over a six-month timeframe. Illustrated hereis the right column of the report.

FIG. 3A illustrates solving the problem of performing the full size 10cm×10 cm grid Amsler test on a typical smart phone with limited screensize.

FIG. 3B shows that by solving the problem of performing the Amsler teston a typical smart phone, the additional capability of validating theaccuracy of the users Amsler test is gained.

FIG. 4A shows Mobile App control flow for the User Logon sequence.

FIG. 4B shows Mobile App control flow for the Survey questions.

FIG. 4C shows Mobile App control flow for the Visual Acuity test.

FIG. 4D shows Mobile App control flow for the Color Vision test.

FIG. 4E shows Mobile App control flow for the 5-Grid Amsler test.

FIG. 4F shows Mobile App control flow for the Generate Test Report andfor sending the report.

FIG. 5A shows Server control flow for the Server Interface services forthe Mobile App.

FIG. 5B shows Server control flow for the Server Storage for UserInformation.

FIG. 5C shows Server control flow for the Server Trends and Analyticsprocessing of stored information.

FIG. 5D shows Server control flow for the Server Rules based generationof Events and Actions.

FIG. 5E shows Server control flow for the Medical Group (MG) UserInterface.

FIG. 5F shows Server control flow for the Clinical Research Organization(CRO) User Interface.

FIG. 5G shows Server control flow for the Server Lead Administrator UserInterface for MG and CRO administrators.

FIG. 5H shows Server control flow for the Server Interface services forthe MG's Electronic Medical Record (EMR).

FIG. 5I shows Server control flow for the Server Interface services forother services, for example feeding home monitoring related activitiesmonthly into the MG's Billing service.

FIG. 5J shows Server control flow for the Server HIPAA Audit SupportUser Interface.

DETAILED DESCRIPTION

The present disclosure provides a means and a method of reportingchanges in the user/patient's vision that have been captured on a mobiledevice through routine self-administered vision-related testing. Thisconvenient testing approach permits the user to use their own mobiledevice on a daily or perhaps alternating day basis to performvision-related testing. The mechanisms for capturing vision-relatedtesting information on the mobile device and the processes forassembling meaningful reports of the captured testing informationtogether with patient related statistics or trends are described herein.

These reports can be printed on paper or transmitted electronically tothe patient's eye care professional or other care professionals forevaluation and, if needed, immediate and/or timely in-clinic follow-up.This report method measurably improves the utility of routine visits byproviding a reporting and alerting mechanism for early intervention, ifneeded, between routinely scheduled in-clinic eye care visits. Enablingearly intervention when vision change is detected will minimize visionloss.

The system described herein also provides long-term storage, comparativeanalytics with prior tests and trend analysis, providing collection forboth user specific results and multiple time-series data. This alsoincludes user data aggregation into populations for research projects.

FIG. 1A illustrates an individual user/patient 112 in a personallocation, such as their home, using a smart phone 116 configured with amobile application (“MA”) to perform vision-related tests 101-110 forthe user/patient, collect results of the tests, and assemble a report114 summarizing the results. In some places herein, we distinguishbetween a “user” of the MA for personal use and a “patient” utilizingthe MA as directed by their eye-care provider to monitor their eyedisease. The MA installed on smart phone 116 takes advantage of nativefeatures commonly found in smart phones, such as the Apple iPhone,Samsung Galaxy or Huawei Ascend, that help the user to perform thevarious vision-related tests. For example, the various smart phonefeatures can be utilized to perform vision-related tests, e.g., tests101-110, including common testing such as Acuity, Color, Amsler grid andothers, as further discussed below. These tests are based upon knownin-clinic tests that are implemented here in digital form to allowfrequent reliable in-home testing and reporting. These testimplementations include unique properties tailored to the advantages ofthe smart phone environment. The ability of the individual to conductpersonal vision-related tests enables early detection of issues andprompt intervention by care providers to minimize vision loss.

FIG. 1B shows a system 190 in which a number of users, such as users124, 126 and 128, communicate the vision test results from theirpersonal smart phones to one or more external resources, such as server150, that may provide storage, analysis, trends, reports, events,actions, and other services, and which can be made accessible to theuser's care providers 158 in accord with HIPAA regulations. The optionalserver-based storage, analytics, trends and reporting of test resultsprovide important data flow reduction and highlighting of test anomaliesfor efficient use of care provider time, as further described below.

MA User Logon

The MA may include a User Logon routine 101 to verify the identity ofthe user/patient 112 intending to use the MA on the smart phone 116 forvision testing 120. FIG. 4A provides a flow diagram of the logon process101. At an initial screen, the user can provide an email address orchoose “Guest User” in step 801. In step 802, the MA determines if thisis a Registered User or Guest. If not a registered user, the MA setsGuest mode in step 803 and proceeds to surveys and tests in step 805. Ifthe MA determines that the user is a registered user in step 802, thenin step 804 the MA validates the email address together with the PINentered by the user with the server 150 using the HIPAA compliantnetwork connection 132 to the server. Once validated, the MA proceedswith surveys, tests and reports in step 805 described further below. Inparallel, the MA monitors inactivity timeout or logout or other testinginterruption flags in step 806 in order to protect the Registered Usersdata. For Guest user's testing interruption, the related data is erased.

An important feature to consider in interface design is the use by thenon-technical elderly person or those with finger tremor, for example,through the design of button layout, size, persistence of finger touch(tremor), eliminating duplicate presses, and readability.

MA Survey for Glasses

The MA includes a Survey for Glasses routine 102 that asks whether theuser's vision has changed, and determines whether the user currentlywears glasses and is consistent with using them, which is an importantconsideration when evaluating the test results. The MA's surveymechanism supports responses that guide subsequent questions, and also,for the surveys or questions to be periodically updated via a connection132 to the server 150.

FIG. 4B provides a flow diagram of the Survey process 102. In step 811,the start time for this survey is noted and saved. In step 812, theinitial question is asked, and in step 813, the question is answered andthe next question is determined in step 813, then based upon the user'sanswer to the previous question, and the next question is asked in step814. In step 815, the user answers the next question, and the MA checksto see that the necessary questions have been answered. If not, step 813is performed again to ask the next question, and if yes, the survey isfinished and the stop time for this survey is saved. Then the MA checksin step 816 whether all of the surveys have been performed, if no the MAgoes to step 811 to perform another survey in the same manner, if yes instep 816 then all surveys are done. If so, then in step 817, the surveyanswers and start/end times are placed in persistent storage forregistered users or in temporary storage for guest users, and the MAroutine proceeds to the next test after step 837.

MA Visual Acuity

A Visual Acuity test 103 allows the user/patient 112 to perform thistest for the chosen eye which proceeds to display a sequence ofprogressively smaller letters using the Sloan font (an optically correctfont designed for this testing purpose and licensed for this use). Toperform the test properly, the smart phone needs to be held at thecorrect distance from the eye being tested, in this case 40 cm (16inches). Consistent distance from test to test is more important thanexact distance. Visual Acuity is scored with reference to the Logarithmof the Minimum Angle of Resolution (“LogMAR”). Note for reference thatLogMAR level 0 can be converted to “everyday language” as 20/20 vision,a common designation that people recognize but which is more difficultto use for optical calculations. For user convenience we display theLogMAR value adjusted by a multiplier of 10, thus a LogMAR value of 0.30is displayed as a test score of “LogMAR 3”. The correct LogMAR charactersize for display on the smart phone when held by the user at aparticular distance from the eye, is calculated using standard opticalformulas as described in the article by Ted M. Montgomery, OptometricPhysician, entitled “Near Visual Acuity” available at web location:<http://www.tedmontgomery.com/the_eye/acuity.html>.

The test sequence proceeds by displaying a letter on the smart phone andhaving the user identify the letter by touching the corresponding choicebutton in the smart phone display with the same letter displayed uponit. When the letter is successfully identified, the size of the letteris reduced by one LogMAR step and the identification choice mechanism isrepeated. When the user fails to identify a letter two times in thetest, the resultant score from the test is the last successful LogMARlevel accomplished. It may be a user with good vision will correctlyidentify all letters to the small size and LogMAR −1 becomes the user'sscore. It may also be the user is unable to identify any of the letterspresented and then the user score is “worse than” the highest LogMARlevel presented, currently LogMAR 11. Further our approach optionallyincorporates variable contrast in the display letters which increasestest sensitivity and provides further diagnostic data to the careprovider.

FIG. 4C provides a flow diagram of the Visual Acuity test sequence,beginning with choosing the eye for testing in step 821, therebyprompting the user to cover the other eye and saving the test starttime. A random Sloan font test letter is chosen in step 822. Next, theletters for display on the buttons are randomly chosen and randomlyplaced on the buttons of the smartphone in step 823, where one of theletters is the correct letter about to be tested. The Sloan testletter's font size is set in step 824, then the test letter and choicebuttons are displayed on the user's smartphone in step 825, and the usermakes a choice in step 825. The user's response is scored in step 826,and if the score indicates that the user has made a good choice (i.e.,the user has correctly identified the letter), then in step 828 the testroutine proceeds to reduce the font size to the next lower logMAR level.Then the process is reviewed to see if testing is done in step 829. Ifnot, the process returns to step 822 to test with the smaller letterprepared in step 828.

If the user's response does not score well (i.e., the user did notcorrectly identify the letter) in step 826, then the process determineswhether the user has incorrectly identified this letter twice (doubleverify mode) in step 827. If not, then the process prepares a differentcurrent size letter in step 827 to give the user another chance toidentify the current letter. Then the process is reviewed to see iftesting is done in step 829. If not, the process returns to step 822 totest with the letter prepared in step 827.

In the “Double verify” mode, each LogMAR level is verified twice in step826, and selection by the user of two good choices causes the score tomove down one logMAR level in step 828 and continue testing in step 829.However, with a second bad choice then step 827 ends the test. As thetest ends, the end time and test results are stored, and the score isthen displayed to the user in step 830.

MA Color Vision

The Color Vision test 104 displays a sequence of selected Ishihara'scolor plates for the chosen eye. An explanation of the well-knownIshihara plates can be found at the following links to web-basedarticles: <https://en.wikipedia.org/wiki/Ishihara_test>and<https://web.stanford.edu/group/vista/wikiupload/0/0a/Ishihara.14.Plate.Instructions.pdf>.

Commonly referred to as the “colorblindness” test, these test platesalso provide diagnostic information for multiple other medical problems.As implemented in the MA, the plates have been selected to demonstratecertain abnormal characteristics familiar to eye care providers. Thetest proceeds with a randomized presentation of selected plates andrandomized choice buttons that include the choice associated with normalcolor vision and additional choices that an eye care provider willassociate with abnormalities.

FIG. 4D provides a flow diagram of the Color Vision test sequence,beginning with choosing the eye for testing, prompting the user to coverthe other eye, and automatically saving the test start time in step 831.Standard Ishihara color plate 12 begins the test with randomized colortest plate choices thereafter in step 832. The response button choices,including the “normal” and certain “abnormal” choices, are randomized instep 833. Then the test color plate and choice buttons are displayed andthe MA waits for the user's choice response in step 834. The user'sresponse is received and scored in step 835, and if still testing instep 836, the test cycle repeats with the random selection of one of theremaining color plates in step 832. When all of the plates have beendisplayed and scored, the test ends, the end time and test results arestored, and the score is then displayed to the user in step 837.

MA Amsler Grid

The Amsler Grid test 105 is a tool that eye care providers andindividuals can use to detect vision problems resulting from damage tothe macula (the central part of the retina) or the optic nerve. Thedamage may be caused by macular degeneration or other eye diseases orother diseases that affect the eye or by pharmaceuticals that may haveside effects on the eye. The Amsler Grid is useful in detecting theseproblems and if found the user should promptly seek eye care. See thearticles at <http://amslergrid.org/>;<https://health.ucdavis.edu/eyecenter/pdf/amsler_grid.pdf>; andhttp://www.myvisiontest.com/about.php.

The examples described herein are sized for a typical smart phonedisplay, but could be sized for effective use on other displays whilemaintaining the required size square of 0.5 cm. The standard Amsler 10cm×10 cm grid has squares of 0.5 cm size which properly used represent aone-degree area on the retina inside the eye. The correctly sized squarehelps eye care providers understand the accurate location of problemsinside the eye. The test proceeds to display a unique sequence of 5grids, as shown on FIG. 3A, with a vision Fixation Point (FP) located oneach grid, the grids labeled A 618, B 610, C 612, D 614, and E 616. Thefirst grid A represents the central 5 degrees of vision with a centralFixation Point (FP) 638, and the other four are each 5 degrees of visionin quadrants around the same central FP 638. The four quadrants in thisexample are illustrated for the right eye as: grid B 610 with superiornasal FP 630, grid C 612 with superior temporal FP 632, grid D 614 withinferior temporal FP 634, and grid E 616 with inferior nasal FP 636.These five grids are drawn separately are marked upon separately by theuser, and then the grids are composited together into grid 650 to createa single 10 cm by 10 cm standard Amsler grid. This approach allows thecreation of the standard Amsler grid using the smaller screen of thetypical smart phone. The user's mark and categorization process usingfinger or stylus drawing on the screen and audio/response is describedfurther in the section below.

FIG. 3B shows how the 5-grid approach enables the validation of usermarks on the screens where the central grid A 718 is overlapped by the 4quadrant grids B, C, D, E to determine and score the user's grid markingconsistency. For example, the user makes a mark “X” 732 on the centralgrid and then proceeds to complete the 4 quadrant grids with a mark “Y”730 on grid C 712. When the test composites the 5 grids 750, the markshows at “Z” 734 and the test also matches the marks “X” 732 and “Y” 730to create a grid marking consistency score. All of the marks andmatching score are provided to the eye care provider via the server 150or on the user's report as discussed in the related section below.

FIG. 4E provides a flow diagram of the 5 Grid Amsler test sequence,beginning with choosing the eye for testing, prompting the user to coverthe other eye and saving the test start time in step 841. In thisdescription reference is also made to FIG. 3B on document 700. Displayof the central grid 718 begins the test where a grid with a centralfixation point is displayed.

Note the successful Amsler marking depends on continuous focus at thefixation point, therefore a unique characteristic of this implementationis the use of audio/response to avoid user eye movement and maintainaccurate grid marking. Uniquely, and for HIPAA privacy compliance, theaudio/response feature is contained completely inside the Mobile App.

The fixation point is black with a pulsing white dot that indicates theuser can mark on the grid with their finger drawing a shape representingany vision defects the user sees while focused on the fixation point.The marking process includes mark completion capability in case theusers' mark end points are not closed or run off the edge of the grid.The users mark is shaded blue and the test's audio/response uses thespeaker of the smart phone to verbalize a series of categoriesdescribing the nature of the mark 732 in step 843. These categoriesinclude “crooked”, “double”, “light gray”, “medium gray”, “heavy gray”,“dark”, “uncertain” and have the same meanings as used to identifymanual markings on a standard paper Amsler grid. After the verbalizationis complete the microphone of the smart phone is turned on and thecentral fixation point stops pulsing and turns solid indicating the usershould respond verbally by choosing one of the categories. The testlistens and identifies the user's response 844, confirming the responseby repeating the category to the user through the smart phone speaker.The user is asked to verbally confirm the category through themicrophone. If not confirmed, the user is given the opportunity tolisten to the categories again and respond again. When confirmed, theusers mark is filled with the category specific shading/marking in step845. The use of audio response allows the user to maintain focus on thefixation point and prepare to make any additional marks with theirfinger in step 846. When the user has made all of the marks on thisgrid, they press the “Next” button to proceed to the next grid in step847. After the user marks all five grids, or skips some with no marks,the user presses the “Done” button 847. The test finishes by assemblingall five grids and displaying both the central grid and the assembledquadrant grids to the user, then waits for the “Ok” response in step848. When the user confirms the grid display, the test ends, the endtime and test results are stored in step 849.

MA Dexterity

The Dexterity test 106 requires the user 112 to place their finger onthe screen and move icons from one position through an obstacle courseto another position for nine iterations. In each of these iterations,the accuracy of the movement is measured by contact, or not, between theicon and the obstacles. As the iterations proceed, tolerance for iconmovement is reduced so difficulty for accurate movement increases and ismeasured by the test.

MA Cognitive

The Cognitive test 108 requires the user to match two rows of presentedinformation, touching the second row to indicate the choice, and wherethe presented information, typically a color, does not match theassociated text, and where the choice row can match either the color orthe text. This creates cognitive dissonance, and the number of correctand erroneous choices are measured by the test.

MA More Tests

The server 150 could add update the MA to add other tests of the user'scapabilities to extend disease related testing features for in-homemonitoring and reporting to care providers.

MA Personal Test Result Report

An example of a “Personal Test Result Report” 114 is created by the MAon the smart phone 116 and provided to the user as both an immediatereport formatted for on-screen display as illustrated in FIG. 2A1 and asretainable report formatted for printing on paper or for sending as anattachment for digital delivery e.g. by email as illustrated in FIG. 2A2The reports can be generated by the MA at any time in the testingsequence, and the generated report will contain time-stamped testresults for recently completed tasks (typically within the last fourhours) or indicate no results are available when a particular test hasnot been completed within the test window.

The report representations of test results have unique characteristicsdeveloped specifically for rapid interpretation by eye care providers.These test results are viewable both on screen as a single column FIG.2A1 and optionally as a two-column display formatted for printing FIG.2A2 that is available to both registered and guest users of the MA foremailing via the user's own email account to any one or more persons ofthe user's choice. HIPAA compliance is not required by regulations whenthe personal health information is entirely in control of the user onthe user's own smart phone device and delivered using the user's ownemail account.

The MA's personal on-screen report display begins with results for theleft eye of the user FIG. 2A1 having five distinct sections: The firstsection 210 is identifying information for the user 212 and optionallycare-provider 214. The second section 220 is survey results. The thirdsection 230 is Visual Acuity test results. The fourth section 240 isColor Vision test results. The fifth section 250 is the left eye 5-GridAmsler plot results, including the central 5 Degree grid 252 in thiscase with the user's mark 254, then also the Central 10 Degree grid 256in this case with the user's mark 258 corresponding to the same marklocation as above 254. Other marks 257 show on the peripheral portion ofthe larger gird. Then scrolling farther down (not shown), the on-screendisplay would show the right eye results in the same format in thecorresponding sections for Visual Acuity, Color Vision and 5-GridAmsler.

The MA's personal printable format two column version FIG. 2A2 containsthe same information described above for FIG. 2A1.

FIG. 4F is a flow diagram of the of the Personal Test Result Report bythe MA. When requested by the user, the report generator uses testtime-stamps to calculate the completion time of the last test taken andthen establish a test reporting time window that includes, typically theprior four hours. The report will contain all test results occurring inthat time window in step 851. The report is generated in step 852 insections as described above typically including blocks 210, 220, 230,240, and 250, as shown in FIG. 2A1 and FIG. 2A2. The reportrepresentations of test results have unique characteristics developedspecifically for rapid interpretation by eye care providers. The reportis initially viewable on the screen of the user's smartphone in step852. After reviewing the report, the user optionally selects thedelivery method in step 853. The Guest option is configured for hardcopy MA report only, while the registered user can transmit to theserver 150 and also create the MA report for device delivery. The MobileApp asks for preferred delivery method(s) in step 854 and verifies theuser type in step 855. For server delivery, a HIPAA compliant connectionis made to the server and the test results are delivered in step 856.For direct digital delivery the MA requests destination name and emailinformation in step 857 then invokes the user's smart phone native emailsystem with a preformatted email and digital report attached (typicallya PDF digital format could be used). The user has the opportunity to addor modify the covering email text before pressing send for the emailwith the attached report in step 858.

MA Privacy, PHI, HIPAA and GDPR

The MA operates entirely within the user's own smart phone device whereunder HIPAA and GDPR regulations the user/patient is free to handle anddistribute his/her own information as they see fit. Thus, for the user'sown vision tests, the relevant test data is collected by the MA on theuser's smart phone during a testing period, organized using relevantcriteria and formatted into the user's MA report 114, as furtherdetailed in FIG. 2A1 and FIG. 2A2. The MA generates the test resultsreport for the user/patient's own use, all on the user's device.

Server Privacy, PHI, HIPAA and GDPR

In another embodiment, underlying any of a system 190 which includesserver 150 based interactions are federal regulations for the securityand privacy of the user's Personal Health Information (“PHI”) (seeHealth Insurance Portability and Accountability Act of 1996 andsubsequent regulations),<https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html>.In Europe, the General Data Protection Regulation (GDPR) is a frameworkfor data protection laws that cover healthcare and related organizations(see the following article discussing GDPR and health care and relatedEuropean Union GDPR regulations),<https://www.pega.com/insights/articles/gdpr-and-healthcare-understanding-health-data-and-consent>.Under these regulations, third parties handling the user's PHI arerequired to comply with user consent requirements and maintain thesecurity of and access to such information according to user/patient'sauthorizations. Because this system in some embodiments transmits,stores the user's PHI and makes the PHI available to user authorizedthird parties, the system design incorporates the necessary designelements and operating processes that make the system HIPAA and GDPRcompliant.

Server Interface for Mobile App (MA)

As briefly described above, FIG. 1B shows a system 190 which includes aserver 150 for handling a number of users, e.g., users 124, 126 and 128,etc. Each user/patient uses their smart phone to take surveys and tests101-110, generate a test report 114, and communicate test results over aHIPAA compliant communications link 130, 132, 134 to HIPAA compliantsystem 150, which provides storage, analytics, trends, events,communications, actions and the server may include optional services orinterfaces. System 190 in turn provides care providers 158 withhistorical and current analysis of results 138 thereby allowing careproviders to more effectively manage the user/patient's treatmentoptions. For example, the device 116 of user 124 sends the collectedtest data and report(s) collected in the testing period using aPHI-secure communication link 130 to connect to a PHI-secure system 150,for example, a computer-based device such as a server.

FIG. 5A provides a flow diagram of an interface process 860 of theserver 150 for services provided to the MA, for example, as installed onuser device 116. In step 861, the MA initiates a HIPAA secure connection130 between the MA 116 and the server 150. Each time the MA opens aconnection to support the MA operation, the MA uses one or more of theserver 150 services 862 that may include:

-   -   1) Server to validate a MA logon user email and PIN for user        validation. The server 150 checks registered users and responds        to the MA with either a) the user is valid/registered, or b) bad        email or user not registered, or c) bad PIN, or d) error 863        (see below).    -   2) Server to update PIN for MA user's associated email. The        server 150 checks registered users for MA user email and a)        sends PIN update instructions to registered email and notifies        MA PIN update email was sent, or b) tells MA email not        recognized, or c) error 863 (see below).    -   3) Server to update/add MA user's surveys when MA sends user's        survey version info and requests updates. Server 150 checks MA        registered user's survey version info and responds a) no survey        updates or adds, or b) sends for user the version x survey        update or add package, or c) error 863 (see below).    -   4) Server to update/add MA registered user's test components        when MA sends user's test version info and requests updates.        Server 150 checks MA registered user's test component version        info and responds a) no test updates or adds, or b) sends for        user the version x test component update or add package, or c)        error 863 (see below).    -   5) Server to update/add MA user specific test plan from Care        Provider when MA sends user's test plan version info and        requests updates. Server 150 checks MA registered user's test        plan version info and responds a) no test plan updates or adds,        orb) sends user's version x test plan update or add package,        or c) error 863 (see below).    -   6) Server to receive survey and test results from MA for the        registered user and responds a) results received, or b) error        863 (see below).    -   Note: Error step 866, in all error cases the server 150 logs the        error and provides a) action to take www, b) error description        xxx, c) error code yyy, d) date ddd, time ttt, and unique error        ID zzz, and e) supplementary information including help contact        information appropriate for that error situation. The routine        exceptions like “bad PIN” are handled above in the routine        server 150 dialog with the MA. The remaining errors handled here        are typically message version errors and malfunctions in the        communication with the MA. For example, communication network        errors, encryption errors for transmitted messages to/from the        MA, message version errors where the version of the information        sent from the MA is unable to be processed by the server 150.        Version information assures the Survey and Test information are        processed correctly. Communication and version exception        handling is initiated here by notifying both the system        administrator and the identified help contact for that user.

As each service request 862 is completed by the server 150, it checks tosee if the MA is finished making requests in step 864. If no, servicerequest processing continues by returning to step 862. If yes, theresults of MA interactions are finalized in the server storage in step865, and the server confirms to MA that the interaction is complete anddisconnects in step 867. Every activity on the server 150 stores Auditinformation 867 (further described below with regard to Audit 166).

Server Storage for User Information

The HIPAA and GDPR compliant server 150 provides secure anonymizedstorage of User's PHI, and may include optional services or interfaces.To accomplish these features, the server 150 implements anonymization ofUser's data using keys, encryption and hashing techniques together withPHI-secure communication links 170. Highly scalable implementationtechniques are used in recognition of the expected high volumes of testand analysis data and rapid access required for a highly responsive UserInterfaces 136, 140, 142, 146, 147, 148 (detailed in subsequent sectionsbelow).

The server 150 can also be configured to aggregate and anonymize thetest data and analytics results and to provide those test results viainterface 146 for the use of clinical trial research teams 162 and theirenrolled users/patients. To complete the security envelope forHIPAA/GDPR compliance, the server 150 depends upon the underlying securedata centers with physical and network access controls, securityfirewalls to prevent cooption by malefactors common on the Internet. Theunderlying platform configuration provided by the data centers includemultiple physical devices and load balancers to maximize service levelsand which are designed for secure data protection, load scalability,backup and recovery. Physical access to the equipment is monitored withcameras and security locks. Equipment service is only via securityverified professionals and their access and work is logged into theaudit system. Updates to the production server are all made by automatedJenkins deployment transfers (seehttps://en.wikipedia.org/wiki/Jenkins_(software)) from the securestaging version of the server where all changes to server features andunderlying operating systems and services are verified before transferinto production.

FIG. 5B provides a flow diagram of user information storage using server150. To store or access user information, the server 150 first convertsthe user key into an anonymous key using a hash technique in step 871.There are multiple data structures for various aspects of the user'sdata and derived analytics data. The data to be stored for the user isstructured according to its particular purpose and then stored orupdated into the data store using the anonymous key in step 872. Thestructures used to store the user's data are designed with human factorsin mind with some derived elements pre-calculated in storage so the userinterface provides rapid response in step 872. The accesses to the userdata storage are entered into the audit log, and every activityperformed on the server 150 stores audit information in step 873(further described below with regard to Audit 166).

Server for Analytics and Trends

FIG. 1B shows an embodiment of this system 190 which includes the server150 for Analytics and Trends and other services. System server 150 alsoperforms ongoing real-time analysis of test data to create time seriesdata and trend displays, such as sections 420 430, 440 on FIG. 2C1 andrelated displays on FIG. 2C2, FIG. 2D1, and FIG. 2D2, as well as relatedevents and considerations in sections 450, 490, 550, 590. This reportprovides important context information about changes in the user's eyecondition over time to the eye-care provider making recommendations fortreatment or other action by the user. FIGS. 2C1 and 2C2 shows anexample of a time series chart 400 displaying a one-month period byselecting button 416, and FIGS. 2D1 and 2D2 shows an example of a timeseries chart 500 displaying a six-month period by selecting button 516.12-month and 24-month time frames are also available as is analternative for time series presentation providing a 30 day or longersliding window. These longer time frames provide additional contextualinformation for stability indicators or slowly changing trends that arenot clear in shorter time frames.

Sections 420, 430, and 440 on FIG. 2C1 and corresponding sections ofFIGS. 2C2, 2D1, and 2D2 implement the unique trend report displaydesigned for rapid care provider recognition of problem areas and likelycauses in just tens of seconds. The group of trend charts each displayin a downward direction both the magnitude and problem category for eachtest result. All of the reports are designed with “up” is better and“down” is worse so the magnitude of problem areas, for example in graphextremes 428, 438, 448, and the types of problems displayed in the colorcoding 447 and texture 427 are immediately apparent in the displaygraphic. In one look for tens of seconds, the care provider is seeingall the related information from 50,000 to over 1,000,000 test points asdescribed below. Because of the rapid display and pre-calculation designof the server 150, the eye care provider can also flip through multipletrend charts, look at individual test results and do multi-chartcomparisons in seconds.

The MA single test result report 114 submitted by the user to the server150 in this example for 3 different tests for both eyes contains fromabout 1,000 to 7,000 data points for charting and analysis. Therefore,the display 400 of trends for one-month of daily test reports for asingle user results in representing somewhere between 30,000 and 210,000data points on the report. Over a six-month period for the relatedreport 500, the numbers are between 180,000 and 1,260,000 data pointsrepresented on the report. The system server 150 is designed to scale-uptest processing for analytics to many tens of thousands of users andstores precomputed analytics to support rapid report display 138 forcare providers. On this system, to the largest extent possible, testdata results are analyzed and precomputed results stored in a short timeafter the test results are received. In the case of the Amsler stylegrid test FIG. 2B1 for each eye, the analysis includes for each mark theuser makes on the grid 352 and 354 (which can be irregular shaped and ofany size):

-   -   1) Counting the number of marks by category (and also the grays        as a category group);    -   2) Determining the size of each mark in fractional grid squares;    -   3) Totaling the number and coverage of grid squares by category        (and also the grays as a category group);    -   4) Calculating the distance of each mark in millimeters between        the mark's closest edge point and the fixation point 351;    -   5) Identifying any marks that touch or cross vertical or        horizontal medial lines;    -   6) Matching marks made on the central grid 352 with marks made        on the four-quadrant grids 354 to check for marking correlation        as a score representing user marking consistency. For example:        See the marks on the central grid 352 and the four-quadrant        grids 354 in FIG. 2B1.

Analysis includes comparing these test report results with prior reportsto compute trend lines, for example, on FIG. 2C1 see sections 420, 430,440 and on FIG. 2C2 see sections 460, 470, 480. The results of these“precomputed calculations” are stored along with the original test datato support rapid display for care providers and for further analysis.

FIG. 5C provides a flow diagram of the Analytics and Trends process ofserver 150 for the user's test results. The just received User's testresults report is obtained for analysis in step 881, including:

-   -   1) Update data plots in step 882;    -   2) Score grid mark reliability by matching marks between the        central and four quadrant grids in step 883;    -   3) Compute mark sizes and locations for each category type and        for the grays category group in step 884;    -   4) Identify marks that cross the fixation point, vertical or        horizontal axes in step 885;    -   5) Update trend calculations with new data in step 886;    -   6) Using the unique trend display representations as discussed        above, precompute single date reports and trend reports for        rapid display in step 887;

The added results are stored in the server along with the user's testreport data in step 888, and the accesses to the user data storage areentered into the audit log in step 889 such that every activityperformed on the server stores audit information (further describedbelow with regard to Audit 166).

Server for Events and Actions

System server 150 performs ongoing rules-based analysis of user'sincoming test reports by comparing the just-received and processedinformation stored for that user with prior test data and trends forthat user. Rules are configured in the server to compare various dataelements, and if the conditions are met, the server generates either anEvent or an Action. Events are notices communicated via interface 142(further described below in Medical Group User Interface section) to theUser's care provider about the event to enable care provider follow-up.Actions require User's care provider acknowledgement via interface 142and identifying an action to be taken about the change in statustogether with the User. For example: a rule is established that if aUser's Amsler grid mark moves more than two degrees (two grid squares)closer to the fixation point 351, an Action is initiated for contactingthe User for a status check, to re-take the test, and if results areconfirmed, a clinic visit. Rule parameter values can be a) default, b)adjusted for a particular User, c) assigned according to a group ofUsers with the same medical disease diagnosis, d) related to members ofa particular Clinical Trial, or adjusted in additional ways.

When an Event or Action occurs based upon meeting the criteria of arule, the notice of the Event or Action can go via interface 142 to oneor more staff at the eye care provider's clinic. However, Actions areassigned and communicated via interface 142 to one specific accountableperson (with copies to others) and that person must Act on the noticesand that action is tracked along interface 142 by the server 150 system.

FIG. 5D provides a flow diagram of the Events and Actions process forthe user's test results using server 150. In step 891, thejust-received, processed and stored User's test results report initiatesthe Rules processing of the new data. Events and/or Actions are thengenerated based upon applicable rules for the User in step 892, and theEvents and/or Actions are communicated by interface 142 to responsiblecare provider (Medical Group) persons in step 893.

The rules processing continues to identify previous Actions not yetmarked as complete and overdue in step 894. Further communication byinterface 142 is made for overdue Actions to responsible care provider(Medical Group) persons in step 895. The Results in User's data and inEvent/Action processing are stored in queues in step 896. Once again,entered into the Audit log are a) accesses to the user data storage; andb) any related Events or Actions, such that every activity on the Serverstores Audit information in step 897 (further described below withregard to Audit 166).

Server Medical Group (MG) User Interface

As shown on FIG. 1B, the Medical Group (MG) User Interface (MGUI) 142together with the server 150 Tests & Trends Result Report(s) 138 are thecare provider's (and care provider's administrative staff) primaryinterface to information on the server 150. Notices of Events andActions are managed through the MGUI. The Reports 138 include the User'ssingle test report shown on FIGS. 2B1 and 2B2 as provided via the server150 to the care provider 158 (it is a replica of the version of thereport generated on the Mobile App augmented with additional MA testresults (if any, for example Dexterity 360, Mobility 370, or Cognitive380) and care provider identification information 314. The Reports 138include examples of time series and trend charts as shown on FIGS. 2C1and 2C2 for a one-month or 60-day period as selected by button 416 andon FIGS. 2D1 and 2D2 for a six-month or 180-day period as selected bybutton 516. Button options for generating 12-month and 24-month reportsare also provided. The elements on the two examples are the same exceptfor the time span the reports cover. The data presented in the examplesare for both eyes and three tests.

In each example chart 420, 430, 440, the system design (discussedpreviously and further here) uniquely displays the data so that it isall oriented the same way for rapid, accurate, care providerinterpretation. Data points near the top of the chart (such as datapoint 434) are favorable to the user status and points lower in a chartare unfavorable (such as data point 438). This chart data orientation iscritical to the eye care provider's correct and rapid evaluation of thetest results. In the provider's clinic setting, significant providertime is saved by this display approach. The charts 138 displayed by thesystem are accessed via interface 140 by care providers 158, and becauseof the server's precomputing step, the care provider can rapidly “flip”through different time periods using the active selector buttons 416,441 as well as immediately drill down to the User's single test reporton a particular day (see FIG. 2B).

A more detailed examination of FIGS. 2C1 and 2C2 illustrates one exampleof a report including the user's one month historical and comparativeresults and trends from previous and current tests, including results ofthe Acuity Test in graph 420, results of the Color Test in graph 430,and results of the 5-Grid Amsler Test in graph 440, as well as relatedevents and considerations in section 450 of the report. In the Acuitygraph 420, there are areas of stability 424, a short term worseningevent 425, missing tests area 426, a longer term worsening event 428,and a return to prior vision acuity area 429. These same characteristicscan be seen in the other two results for Color Test 430 and Amsler test440. Note also that these two test's displays also distinguish thecategory of problem by using color coding and shading 427 and 447 inaddition to magnitude for the severity. This report's display designprovides important context information across time and tests aboutchanges in the user's eye condition that can be rapidly evaluated forspecific concerns and longer-term trends. This enables the care providedto see whether the current test results indicate an improvement ordecline in user's status and the trend's rate-of-change as seen by thelarge deviations 428, 438, 448. This substantially improves the eye careprovider's ability use status-guided considerations as shown in section454 and to note events/actions 452 thereby enabling the eye careprovider to make informed recommendations for care and other action bythe user.

Another capability of the presentation design is the detail 427 in theAcuity Test results showing the effects of contrast in the test resultsand in region 427 of the Acuity Test. In a similar manner the detail inthe 5-Grid Amsler Test showing the size and type of defect markings 447,where in this example, 75 percent of the user's visual field is impactedat the worst point in the event and 12 percent is completely black, asindicated by region 447. Very important details are thus quicklyavailable to the care provider.

In a similar manner, FIG. 2D1 shows a longer time series and plainlyshows serious deterioration in the User's vision over the past 180 days.This trend is not nearly as obvious when looking only at the one-monthreport in FIG. 2C1. The ability of the server 150 to quickly show theReports 138 with important information and over different time frames atthe click of a button 416 or button 516 means the care provider willmake better decisions sooner than possible when only periodic in-clinictesting is used. This will likely improve care and preserve more of thepatient's vision than current practice methods enable. PHI-securecommunication links 140 and 142 are provided for communications withcare providers 158. The User's own communication links 160 can be usedby care providers to interact with their users/patients 124, 126, 128(and more).

FIG. 5E provides a flow diagram of the process for using the ServerMedical Group (MG) User Interface 142. An eye care provider 158 or amember of their staff with necessary credentials can logon to the server150 in step 901 using the server MGUI via HIPAA compliant communicationlink 142. As part of the logon process, the MGUI looks at thecredentials of the person logging on for their assigned roles andprivileges (which may be group participation related) to apply HIPAAcompliant restrictions to this particular MG user that will 1) restrictaccess to permitted data and 2) enable only permitted actions, in step902. Complying with the aforementioned roles and privileges, the MG Userselects to work with 1) MG Events & Actions; 2) MG User/patientinformation; or 3) Clinical Trial (CT) activities, in step 903. MG Userreviews the display of related data in step 904 and initiates actions asneeded in step 905. If the MG User is not done in step 906, the processreturns to step 903 to handle more activities. When MG User is done instep 906, or after an inactivity timer expires, the MG User logs out.Entered into the Audit log are a) accesses to user data storage; b)display of user data; c) any related Events or Actions; and d) any CTactivities, such that every activity on the Server stores Auditinformation in step 907 (further described below with regard to Audit166).

Server Clinical Research Organization (CRO) User Interface

Clinical Research Organization (CRO) User Interface (CROUI) 146 is theprimary interface for the Clinical Research Organization (CRO) staff 162(and CRO's administrative staffs) to information on the server 150.Notices of CRO Events are managed through the CROUI. The CRO works withanonymized data for a population of enrolled Clinical Trial (CT)patients. The server 150 can provide the CRO appropriate access toanonymized data for the CT population. Also, the server 150 can providefor the CT population aggregated time series and trend charts formultiple patients that appear similar to the reports shown on FIGS. 2C1and 2C2 for a one-month period and on FIGS. 2D1 and 2D2 for a six-monthperiod. The elements on the two examples are the same except for thetime span the reports cover. PHI-secure communication links 146 areprovided to CRO staff 162. A PHI-secure communication link 157 is alsoprovided for interaction between CRO staff 162 and MG care providers158.

FIG. 5F provides a flow diagram of the process for using the ServerClinical Research Organization (CRO) User Interface 146. A CRO staffmember 162 or a member of their staff with necessary credentials canlogon in step 911 to the server 150 using the server CROUI via HIPAAcompliant communication link 146. As part of the logon process, theCROUI looks at the credentials of the person logging on for theirassigned roles and privileges (which may be group participation related)to apply HIPAA compliant restrictions to this particular CRO user thatwill 1) restrict access to permitted data and 2) enable only permittedactions, in step 912. Complying with aforementioned roles andprivileges, the CRO User selects to work with 1) Clinical Trial (CT)configuration/management; 2) CT anonymized multi-patient data & trends;3) the CT's patient list; 4) CT's patient informed consent records; or5) CT's Medical Group (MB) list, in step 913. CRO User reviews displayof related data in step 914. CRO User initiates actions as needed instep 915. If the CRO User is not done in step 916, the process returnsto step 913 for more activities. When the CRO User is done in step 916,or after an inactivity timer expires, the CRO User logs out. Enteredinto the Audit log are a) the accesses to CT data storage; b) display ofCT data; c) any related CT Events; and d) any CT activities, such thatevery activity on the server stores audit information in step 917(further described below with regard to Audit 166).

Server Lead Administrator (LA) User Interface

FIG. 1B shows that the Lead Administrator (LA) User Interface (LAUI) 147is the primary interface for Server Lead Administrator (LA) 164 (andLA's administrative staffs) to information on the server 150. There isnormally a LA for each of the Clinical Research Organizations (CRO) orMedical Groups (MG) entities on the Server System. Notices of LA Eventsare managed through the LAUI. The LA 164 performs lead administratoractivities for its assigned entity, either a CRO or a MG. The server 150can provide the LA 164 for a CRO appropriate access to manage the otherCRO staff and also the CT patient population. In a similar manner, theserver 150 can provide the LA 164 for a MG appropriate access to managethe other MG staff and also the MG patient population (includingproposing patents for CT enrollment). PHI-secure communication links 170(not illustrated for brevity) are provided to LA staffs 164 forinteraction with their respective CRO teams 162 or MG care providers158.

FIG. 5G provides a flow diagram of the process for using the Server LeadAdministrator User Interface (LAUI) 147. A LA 164 or a member of theirstaff with necessary credentials can logon in step 921 to the server 150using the server LAUI via HIPAA compliant communication link 147. Aspart of the logon process, the LAUI looks at the credentials of theperson logging on for their assigned roles and privileges (which may begroup participation related) to apply HIPAA compliant restrictions tothis particular LA user that will 1) restrict access to permitted dataand 2) enable only permitted actions, in step 922. Complying withaforementioned roles and privileges, the LA user selects to work with 1)Entities (MGs, CROs or CTs) configuration/management; 2) Members (of MGor CRO); 3) Patient registration (MG or CT); 4) The MG's daily EMRclinic patient visit list; 5) Clinical Trials (CTs); or 6) CT'spatient's informed consent requirements, in step 923. LA user reviewsdisplay of related data in step 924. CRO User initiates actions asneeded in step 925. If the CRO User is not done in step 926, the processreturns to step 923 for more activities. When LA user is done in step926, or after the inactivity timer expires, the LA user is logged out.Entered into the Audit log are a) accesses to MG, CRO or CT datastorage; b) display of accessed data c) any related MG, CRO or CTEvents; and d) any MG, CRO or CT activities, such that every activity onthe server stores Audit information in step 927 (further described belowwith regard to Audit 166).

Server Electronic Medical Record Interface (EMR)

FIG. 1B shows an event driven service interface 144 on the server 150that enables an Electronic Medical Record (EMR) system 154 at a MedicalGroup to use standard protocols to log onto the server 150 withpreviously configured credentials. The EMR provides the server with alist of patients and related data that are scheduled to be seen in theMG clinic that day. The list is used to verify the patients areRegistered Users 124 on the server 150 (or if permitted causeregistration to occur) and, if desired, enable 124 to use a smart phonedevice in the clinic to take the Mobile App (MA) 116 test suite, withresults delivered to the server 150. The information provided by the EMRis sufficient to register the patient on the server and enable the MA tobe used to do “first time use” for a Registered User 124 if the eye careprovider decides the MA test suite should be taken by that patient 124.The server responds to the EMR with confirmation of the patient list andindication as to which patients on the list are identified by the server150 as existing MG patients and which are new MG patients on the server150.

Regardless of the location where the User/patient uses the MA to taketests (at home or in the clinic), a MG member 158 can review thepatient's test results on the server 150. The MG member can specifywhich test result reports should be transmitted in PDF format (otherformats possible) to the EMR 154 for addition to the User/patient's EMRrecord.

FIG. 5H provides a flow diagram for services provided to the EMR 154.Depending on the service to be performed, either the server 150 or theEMR can initiate the secure connection 144 and exchange authorizationcredentials in step 931. In step 932, the EMR services interface 144 canbe invoked that may include: 1) Receipt by the server 150 from the EMR154 of registration information for MG clinic daily planned patientvisit list to support MA 116 testing, or 2) Server 150 transmission toEMR 154 of specified patient reports 138 for inclusion in the patient'sEMR record at the request of the MG care provider 158. The server 150checks to see if service requests are complete in step 933. If not, theprocess returns to step 932. If yes, server 150 causes the results ofEMR interactions to be finalized in the server storage 934, the serverconfirms to EMR that the interaction is complete, and disconnects instep 934. Every activity on the Server stores Audit information in step935 (further described below with regard to Audit 166).

Server Other Services (OS) Interface

As shown on FIG. 1B, a RESTful event driven service interface 149 on theserver 150 enables Other Services (OS) 152 with proper credentials tointeract with the server. It is important for the system and server tointegrate comfortably into the MG or CRO environment. RESTful interfacedesigns and related protocols are typically used for this purpose, andthe server 150 supports this standard interface type to simplifyextensions for integration with other systems where needed. (seehttps://restfulapi.net/). For example, a billing system could collectbillable events from the Server 150. The OS 152 would use standardprotocols to logon the server 150 with previously configuredcredentials. The OS uses, for example, a server transaction to request alist of billable events occurring after a certain date. The server 150verifies the transaction request with the OS credentials and thenprovides the list of billable events after the date specified in therequest.

FIG. 5I provides a flow diagram of the interface for services providedto the Other Services (OS) 152, in this example an external billingsystem. Depending on the service to be performed, either the server 150or the OS 152 can initiate the secure connection 149 and exchangeauthorization credentials in step 941. The OS services interface 149 canbe invoked in step 942 and may include transaction capabilities like: 1)Transmission of billable events to billing system 152, and 2)Confirmation of resulting action on billable events by billing system152. The server 150 checks to see if service requests are complete instep 943. If not, the process returns to step 942 continues. If yes, theserver 150 causes the results of OS interactions to be finalized inserver storage, the server confirms to OS 152 that the interaction iscomplete, and disconnects in step 944. Every activity on the Serverstores Audit information in step 945 (further described below withregard to Audit 166).

Server Audit (A) User Interface (Audit 166)

As shown on FIG. 1B, Audit (A) User Interface (AUI) 148 is the primaryuser interface for a system audit user 166 to access audit informationon the Server 150. Notices of Audit Events and Audit Actions are managedthrough the AUI. For the system 190 and server 150 to be HIPAA and GDPRcompliant, there must be a complete record of all system activities,including viewing PHI, actions with PHI, transmission of PHI to othersystems, all server and system component maintenance actions, allphysical and logical (network) access to the server and other systemcomponents. For each event, the audit logs will include the UTCdate/time, what was accessed, by whom and what actions occurred. The AUIprovides powerful standardized filtering and search capabilities thatenable the Auditor to review events of interest efficiently. This is acomprehensive log and is implemented using ELK (a toolset also used byNetflix, Facebook, Microsoft, LinkedIn, Cisco and many other companies)(seehttps://opensource.com/article/18/9/open-source-log-aggregation-tools).

FIG. 5J provides a flow diagram of the process for using the ServerAudit User Interface 148. An Auditor 166, or a member of their staff,with necessary credentials can logon to the Server 150 in step 951 usingthe server AUI via HIPAA compliant communication link 148. As part ofthe logon process, the AUI looks at the credentials of the personlogging on for their assigned roles and privileges (which may be groupparticipation related) to apply HIPAA compliant restrictions to thisparticular Audit user that will 1) restrict access to permitted data,and 2) enable only permitted actions, in step 952. Complying withaforementioned roles and privileges, the Audit User selects to filterfor common events 1) Logon and Log out; 2) Network accesses (e.g. bylaptop computer or other methods; 3) Any viewed data (option to bepatient specific); 4) Any new or changed data; 5) Any transmitted dataor reports; 6) Any server maintenance; 7) Set customer filters; or 8)Add/flag log entries (not change or delete), in step 953. Filters arefurther refined to narrow results in step 954. The Audit report issaved, if needed, in step 955. If the Audit User is not done in 956, theprocess returns to step 953 for more activities. When the Audit User isdone in step 956, or after the inactivity timer expires, the Audit Userlogs out. Every activity on the Server, including by the Audit User,enters into the Audit log a) accesses to user data storage; b) anyrelated Events or Actions; and c) all audit queries made, reports oradditions, such that every activity on the server stores Auditinformation in step 957.

The invention claimed is:
 1. A process, comprising: receiveidentification of a first user from a first mobile computing devicerunning a vision-related testing application, wherein the first mobilecomputing device includes at least a camera, a display, and a userinterface presented on the display including a touch interface;initiating a first vision-related test by presenting a series of gridsindividually displayed one at a time on the display, each grid having afixation point, wherein the series of grids comprises: a first gridhaving a first fixation point centrally disposed on the first grid; anda plurality of subsequent grids, wherein each subsequent grid comprisesa second fixation point disposed near a peripheral edge of thesubsequent grid; receiving input from the first user through the userinterface in response to each of the series of grids; processing theinput received from the first user through the user interface inresponse to each of the series of grids to generate results of the firstvision-related test derived from the input; and presenting the resultson the display of the first mobile computing device.
 2. The process ofclaim 1, the first vision-related test selected from a plurality ofvision-related tests including but not limited to a visual acuity test,a color vision test, is a central vision test, a dexterity test, and acognitive test.
 3. The process of claim 2, further comprising:communicating the results to a server via a secure, HIPAA-compliantinterface; and generating an analysis of results of at least twovision-related tests from the server, including a trend in the resultsof the vision-related tests.
 4. The process of claim 2, the centralvision test further comprising: wherein each grid being a square havinga plurality of intersecting horizontal and vertical lines disposedsymmetrically on the grid and dividing the grid into smaller squareseach measuring 0.5 centimeters; for each grid presented, receiving amark made by the user on the touch display to represent a vision defectif the vision defect is observed by the user when the user is focused onthe fixation point; combining the series of marked grids into a singledisplay; and storing results of the grid marking.
 5. The process ofclaim 4, further comprising: receiving a selection by the user of afirst eye to test; performing the steps of claim 3 for the first eye;and repeating the steps of claim 3 for a second eye of the user.
 6. Theprocess of claim 4, wherein the series of grids comprises five grids,each grid is a 10 row by 10 column grid, wherein a first grid of thefive grids includes a first fixation point located in the center of thefirst grid, wherein each of the four remaining grids is designated for adifferent peripheral quadrant adjacent the first grid such that a topleft grid has the first fixation point located at the bottom right ofthe grid, a top right grid has the first fixation point located at thebottom left of the grid, a bottom left grid has the first fixation pointlocated at the top right of the grid, and a bottom right grid has thefirst fixation point located at the top left of the grid.
 7. The processof claim 4, further comprising: sending results of the grid marking to aserver via a secure, HIPAA-compliant interface; generating a consistencyscore that describes how similar the marks are on each of the gridsincluding an evaluation of the position of the marks relative to thefixation point.
 8. The process of claim 2, the visual acuity testfurther comprising: presenting a series of successively smaller testletters on the display of the first mobile computing device; and scoringa user's response to each of the presented test letters for one eye. 9.The process of claim 8, the presenting step further comprising: (i)configuring the user interface to display a plurality of responsebuttons having a first set of random letters including a first testletter, the test letter in the first set having a first character size;(ii) displaying the response buttons and the first test letter on thedisplay of the first mobile computing device; (iii) receiving input fromthe user touching one of the displayed response buttons; (iv) when theinput incorrectly identifies the first test letter, re-displaying theresponse buttons with another set of random letters including the firsttest letter and the first test letter again having the same firstcharacter size, wherein a second incorrect identification results in anend to the test; (v) when the input correctly identifies the first testletter, configuring the user interface to display the plurality ofresponse buttons having a second set of random letters including asecond test letter, the test letter in the second set having a smallercharacter size than the test letter in the first set; and (vi) repeatingsteps (ii) through (v) with different test letters having successivelysmaller character sizes.
 10. The process of claim 9, wherein the testletter character sizes are set in accord with LogMAR character sizing,and each successively smaller character size is a reduction by a singleLogMAR step.
 11. The process of claim 9, wherein the scoring isdisplayed as the last LogMAR character size that is correctlyidentified.
 12. The process of claim 9, further comprising repeating theprocess for the other eye.
 13. The process of claim 9, furthercomprising identifying a start time and an end time for the test. 14.The process of claim 2, the color vision test further comprising:presenting a series of color plates on the display of the first mobilecomputing device; and scoring a user's response to each of the presentedcolor plates for one eye.
 15. The process of claim 14, furthercomprising: (i) selecting a first one of the series of color plates atrandom to display; (ii) configuring the user interface to display a setof response buttons, each button indicating a different choiceassociated with the chosen color plate, where the choices are randomlyassigned to the response buttons for display; (iii) displaying the firstrandom color plate and the set of response buttons; (iv) receiving inputfrom the user touching one of the button in the set of response buttons;(v) scoring the input; (vi) repeating steps (i) through (v) for each ofthe series of color plates.
 16. The process of claim 15, wherein thedifferent choices are normal and abnormal.
 17. The process of claim 15,further comprising identifying a start time and an end time for thetest.
 18. The process of claim 1, further comprising: preparing aformatted report summarizing the results; and sending the formattedreport to at least one other device via a secure, HIPAA-compliantinterface.
 19. A vision testing process, comprising: verifying identityof a first user from a first computing device running a vision-relatedtesting application, wherein the first computing device includes adisplay and a user interface to influence the display; initiating afirst vision-related test by separately presenting a series of graphicalimages, one at a time, on the display of the first computing device, andreceiving user input from the first user through the user interface inresponse to each of the series of graphical images; the series ofgraphical images including five grids, each grid comprised of rows andcolumns of open squares, wherein a first grid of the five grids is acentral grid for central vision testing and includes a central fixationpoint located in the center of the center grid, wherein four remaininggrids comprise four quadrant grids with each of the four quadrant gridsdesignated for a different quadrant relative to the center fixationpoint such that a top-left quadrant grid has a bottom-right fixationpoint located at the bottom right of the top-left quadrant grid, atop-right quadrant grid has bottom-left fixation point located at thebottom left of the top-right quadrant grid, a bottom-left quadrant gridhas a top-right fixation point located at the top right of thebottom-left quadrant grid, and a bottom-right quadrant grid has atop-left fixation point located at the top left of the bottom-rightquadrant grid; processing the user input received from the first userthrough the user interface in response to the series of graphical imagesto generate results of the first vision-related test derived from theuser input; and presenting the results of the first vision-related test.